Ground Zero Pharmaceuticals, Inc. provides integrated consultation in regulatory affairs, toxicology, pharmacology, clinical development, biostatistics, CMC, and project management for pharmaceutical, biologic, medical device and combination product programs. GZP also provides Technology Assessment and Due Diligence Services as well as direct assistance with Corporate Management and Company Building.
GZP provides specialized consulting in many therapeutic areas. Some areas of expertise include:
We have rapid initiation and execution phases and the team you meet will be the team that actually follows through to help make your program successful. A highly trained GZP Project Manager serves as the primary contact person for each client, ensuring coordination of information and efforts and providing a central resource for rapid responses.
The pharmaceutical, biologics and medical device industries are changing as they struggle with economic, political and public policy changes. Capital markets have periodically proven less than kind to new biotechnology, pharmaceutical and biologics firms. The translation of innovative ideas into projected profit from new products requires sophisticated analysis. The FDA Modernization Act of 1997, FDAAA and multiple reauthorizations of the Prescription Drug User Fee Act, and FDA’s Critical Path Initiative have provided opportunities for more creatively moving products through the regulatory agency maze. They have also “raised the bar” on standards for data quality. It is vital to develop and plan for effective strategies to hasten the product development process. This involves:
- Establishing a relationship with the FDA and/or State Reviewing Division
- Assessing the technology fairly and objectively
- Selecting those products that will maximize portfolio value
- Providing effective guidance on the needs of the marketplace
- Building an effective strategic plan for speeding product development
- Maintaining confidentiality of medical records and intellectual property
- Creating medical and technical documents that are comprehensive, focused, and easily read
- Managing the process effectively from start to finish, affirmatively making decisions and encouraging others to do the same
The inefficiency and relative lack of benefit for the client in the usual CRO model for consulting services are demonstrated by inordinate delays in the conduct of clinical trials, massive cost overruns, and lack of attention to detail in CRO teams with conflicting priorities. This results in delays in submissions and manufacturing; clinical or technological questions raised late in the review process; and most importantly, delays in product approval. GZP emphasizes a proactive approach to these issues from the very first interactions with our clients and partners. If you demand targeted management, regulatory and product development consulting, prompt attention to detail, individual consideration and first-rate quality, then choose Ground Zero Pharmaceuticals, Inc.